CETRA: Neoadjuvant Caelyx and Trastuzumab in Her-2 Positive Breast Cancer

Sponsor

National Cancer Institute, Naples (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00434031

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the rate of pathologic complete response when giving docetaxel and trastuzumab followed by caelyx (liposomal doxorubicin), cyclophosphamide and trastuzumab before surgery in treating women with operable or locally advanced HER-2 positive breast cancer.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: docetaxel Drug: cyclophosphamide Drug: trastuzumab Drug: liposomal doxorubicin	Phase 2

Detailed Description

Chemotherapy in association with trastuzumab, a monoclonal antibody, given before surgery, has been shown to reduce tumor size and permit better resection of HER-2 positive breast cancers. This study will evaluate the activity of a neoadjuvant treatment with docetaxel and trastuzumab given every 3 weeks for 4 cycles, followed by the combination of caelyx, cyclophosphamide and trastuzumab every 3 weeks for 4 cycles. Patients will undergo breast cancer surgery 2-5 weeks after the completion of neoadjuvant therapy. Adjuvant therapy after surgery will be given according to existing guidelines, and will include an additional 10 cycles of trastuzumab.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Neoadjuvant Therapy With Trastuzumab and Docetaxel Followed by Trastuzumab, Caelyx (Liposomal Doxorubicin) and Cyclophosphamide in Operable or Locally Advanced Her-2 Positive Breast Cancer

Study Start Date :

Sep 1, 2007

Outcome Measures

Primary Outcome Measures

complete pathologic response rate []

Secondary Outcome Measures

toxicity of neoadjuvant treatment []
predictive ability of noninvasive diagnostic methods for results of neoadjuvant treatment []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Histological diagnosis of breast cancer
Stage II-IIIB (T0-1-2-3-4-N+-M0 or T2-3-4-N0-M0; according to TNM AJCC classification,

Hyperexpression of HER-2/neu (HercepTest 3+ or positive FISH test)
Age> 18 e < 65 years
Left ventricular ejection fraction (LVEF) > or = 55%
ECOG Performance Status 0-2
Neutrophils > or = 2000/mm³, platelets > or = 100.000/mm³ , hemoglobin > or = 10 g/dl), GOT, GPT and bilirubin < 1.25 x the upper normal limit, creatinine < 1.25 x the upper normal limit.
Life expectancy > 3 months
Signed informed consent.

Exclusion Criteria:

Any prior treatment for breast cancer
Metastatic disease (M1)
Performance status (ECOG) > or = 3
Current malignancy or history of prior malignancy within past 10 years (with the exception of adequately treated non-melanoma skin cancer and carcinoma in situ of the uterine cervix)
Neutrophils < 2.000/mm³ , platelets < 100.000/mm³ , hemoglobin < 10 g/dl.
Creatinine > 1.25 x the upper normal limit
GOT and/or GPT and/or bilirubin >1.25 x the upper normal limit.
Concomitant conditions that, in the investigator's opinion, contraindicate the use of the drugs in the protocol.
Congestive heart failure or history of congestive heart failure, unstable angina pectoris, myocardial infarction, clinically significant valvulopathy or uncontrolled arrhythmias
Active infection
Incapacity or refusal to provide informed consent.
Inability to comply with follow up
Pregnant or nursing females.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istituto Nazionale dei Tumori, Divisione di Oncologia Medica C	Napoli		Italy	80131

Sponsors and Collaborators

National Cancer Institute, Naples

Investigators

Principal Investigator: Andrea De Matteis, M.D., NCI Naples, Division of Medical Oncology C
Principal Investigator: Giuseppe D'Aiuto, M.D., NCI Naples, Division of Surgical Oncology A
Principal Investigator: Francesco Perrone, M.D., Ph.D., NCI Naples, Clinical Trials Unit